PRECAUTIONS - Device operations and output interpretation Read and understand the content of this user guide before use. Contact brain4care to receive training before operating the BcSs-PICNIW-1000 Sensor. The sensor may only be used by qualified individuals who have successfully completed training with a brain4care representative. The position, or movement, of the patient and the BcSs-PICNIW-1000/BcSs-PICNIW-2000 sensors is known to affect the signal being recorded. As a result, if multiple recording sessions are obtained on the same patient, consistent positioning of the patient and device will lead to more comparable recordings Do not press the BcSs-PICNIW-1000/BcSs-PICNIW-2000 sensor pin with hand or any other object, this may damage the sensor. The derived P2/P1 ratio is an estimated value and therefore carries some uncertainty. The clinician is reminded to use their professional judgment when interpreting this and all waveform information in the report. The signal quality check is NOT a clinical judgement or diagnosis. The is a technical verification and the insufficient signal quality message means one or more of the four conditions below are true: The signal-to-noise ratio is not satisfactory (signal with lack of physiological characteristics) The amount of artifacts is excessive (too much movement being captured in the signal) The processed signal will result in a statistically non-significant P2/P1 ratio Processed signal will result in a non-physiological Time-to-Peak range
If the device functionalities are lost due to EM disturbances, the waveform may not be accurate. Verify with your facility’s clinical engineering team which receiver will match the monitor module plug in your care giving area. Be cautious when handling the headband due to risk of strangulation. Also avoid touching simultaneously the patient and a non medical device due to risk of electrical shock The use of the B4C wireless sensor adjacent to or stacked with other equipment should be avoided. If such use is necessary, the device and the other equipment should be observed to verify that they are operating normally The B4C System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the B4C System helps to prevent electromagnetic interference by maintaining a minimum distance of 30cm (12 inches) between portable or mobile RF communication equipment (transmitters) and the B4C System. The B4C System may be affected by equipment that emits RF signals in the environment in which it is installed. Using the device close to RFID readers can cause temporary loss of wireless functionalities.
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